Organovo Holdings ($ONVO), which has focused its bioprinting technology on fabricating synthetic tissue for testing, said it plans to develop 3D-bioprinted human liver tissue that could be used for transplants.
The San Diego-based company said the new push is based on positive preclinical studies in animal models that showed engraftment, vascularization and sustained functionality of its bioprinted liver tissue. Those studies also indicated stable detection of liver-specific proteins and metabolic enzymes.
That could be good news down the road for patients on liver transplant waiting lists. Currently, about 17,000 people in the U.S. are on the liver transplant list, with only about 6,000 of the transplants performed each year, according to Organovo.
Still, even if everything goes as planned, an Investigational New Drug application won’t be submitted to the FDA for at least three to 5 years. In the meantime, Organovo said that where it’s appropriate it will go after breakthrough therapy designation and clinical development outside the U.S. to help speed up the time to market.
“We believe that 3-D bioprinted tissues have an opportunity to provide options for patients who suffer from liver disorders,” Keith Murphy, Organovo’s chief executive, said in a statement. “The scientific and commercial progress we have already made with ExVive Human Liver Tissue in drug toxicity testing has given us a firm foundation upon which to build a larger tissue for transplant.”
Clinical solutions in two initial areas are planned for development. The first is acute-on-chronic liver failure, which is a recognized and distinct orphan disease encompassing an acute deterioration of liver function in patients with liver disease that affects about 150,000 people in the U.S. each year. The second area is pediatric metabolic liver diseases, another orphan disease indication where a bioprinted liver tissue patch may show therapeutic benefits.
Overall, Organovo estimates the market for the two initial indications to be more than $3 billion.
“In our preclinical studies, we deliver a patch of functional tissue directly to the liver, which integrates well, remains on the liver and maintains functionality,” Dr. Eric Michael David, chief strategy officer and EVP of preclinical development at Organovo, said in the statement. “We believe our tissues have the potential to extend the lives of patients on liver transplant lists, or those who do not qualify for transplants due to other factors.”